Back to resultsEffectiveness of Manual Therapy and Neuromuscular Training in the Management of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Manual therapy techniques
Transcutaneous Electrical Nerve Stimulation (TENS)
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis, Manual therapy, TENS, Neuromuscular training
Eligibility Criteria
Inclusion Criteria: Complaining of knee pain that has lasted longer than 3 months. Pain level that is medium (pain score greater than or equal to 4). No knee injuries. Treatment not received in another physical therapy clinic in the past three months. Painful range of motion in the knee. Exclusion Criteria: History of knee surgery A systemic arthritic condition Any other muscular, joint, or neurological condition affecting lower limb function. Received physical therapy or an intra-articular injection in the knee within the past 3 months.
Sites / Locations
- University of TabukRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Manual therapy with Neuromuscular training
Conventional physical therapy with Neuromuscular training
Arm Description
Manual physical therapy is intended to improve musculoskeletal function and pain by addressing impaired kinematics of the joint. Passive Joint Mobilization (PJM) was applied to knee distraction and dorsal glides, ventral glides, and patellar glides in all directions, which were applied at a rate of two to three oscillations per second for 1-2 min. Each direction was repeated three to six times. Neuromuscular training (NEMEX-TJR training program): (2 times per week for 6 weeks) The neuromuscular training program consists of 3 parts: warming up, a circuit program, and cooling down. The program is performed twice a week for 6 weeks, with each session lasts for 60 minutes.
Physical therapists use a variety of transcutaneous electrical nerve stimulation (TENS) applications to reduce or alleviate pain for individuals with Knee OA. TENS (symmetrical biphasic waveform, frequency 32-50 Hz, pulse width 80 microseconds) for the same amount of time and the same number of days. The TENS electrodes were applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care was taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. Neuromuscular training (NEMEX-TJR training program): (2 times per week for 6 weeks) The neuromuscular training program consists of 3 parts: warming up, a circuit program, and cooling down. The program is performed twice a week for 6 weeks, with each session lasts for 60 minutes.
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale
The average pain intensity over the last week at the time of testing was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible.
Goniometric measurement for ROM
To check the range of motion (ROM) of the knee joint, the joint will be extended as far as it can go while the person is lying on their back three times. The angle at the maximum flexion position was measured with a goniometer, and the average angle was recorded.
Western Ontario and Mc Master Osteoarthritis Index (WOMAC)
It is a questionnaire for the evaluation of treatment results in patients with lower extremity osteoarthritis, and it divides difficulties in daily living into scales. WOMAC scores are recorded on a five-point Likert scale of 0-4, where 0 = no pain or limitation, 1 = mild pain or limitation, 2 = moderate pain or limitation, 3 = severe pain or limitation, and 4 = extreme pain or limitation. Maximum scores for pain, stiffness and physical functions were 20, 8, and 68, respectively, with total scores of 96 indicating greater disease severities.
Short-Form Health Survey (SF-36)
This instrument consists of 36 items, grouped into eight domains: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, and mental health. A measurement scale with values ranging from 0 (the worst health status) to 100 (the best health status) was used to give each subject and each of the eight dimensions a score.
Single-leg stance time test
This test has been used to assess static standing balance in individuals with knee OA. The single-leg stance test was measured by recording the time in seconds (30s maximum) while participants are asked to balance on one leg while keeping their hands on their hips. The test starts when the free foot lifts off the ground and is stopped if: (1) the swing limb touches the ground; (2) the stance foot moves on the floor; (3) the swing foot touches the tested limb; or (4) the hands move away from the hips.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05659849
Brief Title
Effectiveness of Manual Therapy and Neuromuscular Training in the Management of Knee Osteoarthritis
Official Title
Effectiveness of Manual Therapy VS Conventional Physical Therapy With Neuromuscular Training in the Management of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tabuk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to compare the short-term effectiveness of manual therapy with neuromuscular training and conventional physical therapy with neuromuscular training in patients with knee osteoarthritis.
Detailed Description
Knee osteoarthritis (OA) is a major public health problem, characterized by progressive degeneration and loss of articular cartilage, resulting in pain, limitation of movement, imbalance, functional disability, and diminished patient quality of life. Regular participation in physical activity has been recognized for several years as being beneficial in the management of knee OA. The role and effectiveness of manual therapy techniques and conventional physical therapy are evident from the existing literature, but no comparison was found for the combination of neuromuscular training (NMT) in patients with knee OA. Thus, the aim of this study is to compare the short-term effectiveness of manual therapy (MT) versus conventional physical therapy (CPT) with NMT in the management of knee OA after six weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee, Osteoarthritis, Manual therapy, TENS, Neuromuscular training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual therapy with Neuromuscular training
Arm Type
Experimental
Arm Description
Manual physical therapy is intended to improve musculoskeletal function and pain by addressing impaired kinematics of the joint. Passive Joint Mobilization (PJM) was applied to knee distraction and dorsal glides, ventral glides, and patellar glides in all directions, which were applied at a rate of two to three oscillations per second for 1-2 min. Each direction was repeated three to six times.
Neuromuscular training (NEMEX-TJR training program):
(2 times per week for 6 weeks) The neuromuscular training program consists of 3 parts: warming up, a circuit program, and cooling down. The program is performed twice a week for 6 weeks, with each session lasts for 60 minutes.
Arm Title
Conventional physical therapy with Neuromuscular training
Arm Type
Experimental
Arm Description
Physical therapists use a variety of transcutaneous electrical nerve stimulation (TENS) applications to reduce or alleviate pain for individuals with Knee OA. TENS (symmetrical biphasic waveform, frequency 32-50 Hz, pulse width 80 microseconds) for the same amount of time and the same number of days. The TENS electrodes were applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care was taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg.
Neuromuscular training (NEMEX-TJR training program):
(2 times per week for 6 weeks) The neuromuscular training program consists of 3 parts: warming up, a circuit program, and cooling down. The program is performed twice a week for 6 weeks, with each session lasts for 60 minutes.
Intervention Type
Other
Intervention Name(s)
Manual therapy techniques
Intervention Description
Passive joint mobilization techniques are applied to the affected knee joint. For the first week (three sessions), the joint mobilization exercises included grade I or II rhythmic oscillations. During the following weeks, grade III or IV oscillation techniques were applied, depending on the level of tolerance and pain of each patient. In knee distraction, the patients are in a prone position with 50° knee flexion, and the physical therapist applies the techniques. The dorsal and ventral glides was performed with the patient in a supine position.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention Description
Transcutaneous electrical nerve stimulation (TENS) therapy treats pain using low-voltage electric currents. A small device administers the electrical current to or near nerves. TENS treatment inhibits or changes pain perception.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The average pain intensity over the last week at the time of testing was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible.
Time Frame
6 weeks
Title
Goniometric measurement for ROM
Description
To check the range of motion (ROM) of the knee joint, the joint will be extended as far as it can go while the person is lying on their back three times. The angle at the maximum flexion position was measured with a goniometer, and the average angle was recorded.
Time Frame
6 weeks
Title
Western Ontario and Mc Master Osteoarthritis Index (WOMAC)
Description
It is a questionnaire for the evaluation of treatment results in patients with lower extremity osteoarthritis, and it divides difficulties in daily living into scales. WOMAC scores are recorded on a five-point Likert scale of 0-4, where 0 = no pain or limitation, 1 = mild pain or limitation, 2 = moderate pain or limitation, 3 = severe pain or limitation, and 4 = extreme pain or limitation. Maximum scores for pain, stiffness and physical functions were 20, 8, and 68, respectively, with total scores of 96 indicating greater disease severities.
Time Frame
6 weeks
Title
Short-Form Health Survey (SF-36)
Description
This instrument consists of 36 items, grouped into eight domains: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, and mental health. A measurement scale with values ranging from 0 (the worst health status) to 100 (the best health status) was used to give each subject and each of the eight dimensions a score.
Time Frame
6 weeks
Title
Single-leg stance time test
Description
This test has been used to assess static standing balance in individuals with knee OA. The single-leg stance test was measured by recording the time in seconds (30s maximum) while participants are asked to balance on one leg while keeping their hands on their hips. The test starts when the free foot lifts off the ground and is stopped if: (1) the swing limb touches the ground; (2) the stance foot moves on the floor; (3) the swing foot touches the tested limb; or (4) the hands move away from the hips.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Complaining of knee pain that has lasted longer than 3 months.
Pain level that is medium (pain score greater than or equal to 4).
No knee injuries.
Treatment not received in another physical therapy clinic in the past three months.
Painful range of motion in the knee.
Exclusion Criteria:
History of knee surgery
A systemic arthritic condition
Any other muscular, joint, or neurological condition affecting lower limb function.
Received physical therapy or an intra-articular injection in the knee within the past 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DR SHAHUL HAMEED PAKKIR MOHAMED, PHD
Phone
+966502958236
Email
s-mohamed@ut.edu.sa
Facility Information:
Facility Name
University of Tabuk
City
Tabuk
State/Province
North West
ZIP/Postal Code
71491
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UNIVERSITY OF TABUK, PhD
Phone
00966144564042
Email
rec@ut.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Manual Therapy and Neuromuscular Training in the Management of Knee Osteoarthritis
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